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For Companies At a Glance
- Tasks: Lead complex regulatory projects and prepare high-quality documents with minimal oversight.
- Company: Join a dynamic team of regulatory experts in a supportive environment.
- Benefits: Enjoy opportunities for mentorship, client engagement, and professional growth.
- Why this job: Be a key contributor to global projects and make a real impact in the industry.
- Qualifications: Requires a Bachelor's or Master's in Life Sciences and 8 years of relevant experience.
- Other info: Opportunity to manage communications with regulatory agencies and support cross-functional initiatives.
The predicted salary is between 48000 - 72000 £ per year.
Job Description
Senior Regulatory Affairs Manager
Onsite London – Paddington
Overview
We are seeking an experienced Senior Regulatory Affairs Specialist to join our team of regulatory experts. In this role, you’ll work independently with minimal supervision, acting as both a Regulatory Team Leader and subject matter expert across complex global projects. You’ll be a key contributor to regulatory strategy, documentation, client engagement, and project execution within a dynamic and supportive environment.
Key Responsibilities
- Project Leadership: Lead complex regulatory projects, including technical writing and/or managing standalone initiatives, with support from senior leadership when needed.
- Technical Expertise: Prepare high-quality regulatory and technical documents with minimal oversight.
- Client Engagement: Build and maintain strong relationships with clients, offering proactive solutions and representing the regulatory team in client meetings.
- Budget Oversight: Review and manage project budgets, track out-of-scope activities, ensure proper revenue recognition, and challenge deviations where appropriate.
- Mentorship & Training: Provide guidance and feedback to junior team members, contributing to their growth and development.
- Client Presentations: Participate in bid defense and client-facing meetings, both virtually and in person, showcasing regulatory deliverables.
- SOP Development: Draft, revise, or review regulatory standard operating procedures as assigned.
- Initiative Support: Contribute to regulatory or company-wide initiatives and support cross-functional collaboration where needed.
- Regulatory Agency Interaction: Manage communications and meetings with regulatory agencies when required.
Required Qualifications
Education:
- Bachelor's or Master’s Degree in Life Sciences or a related discipline.
Experience:
- Minimum 8 years of relevant experience in regulatory affairs or related field.
- Demonstrated experience in leading regulatory projects and contributing to regulatory strategies.
Knowledge & Skills:
- Strong understanding of the drug development lifecycle (CMC, preclinical, clinical).
- In-depth knowledge of regional regulatory guidelines and marketing authorization transfer (MAT) processes.
- Proven ability to plan and deliver high-quality outputs within deadlines and budget.
- Familiarity with pharmacovigilance considerations related to MATs.
- Competent in Microsoft Office and regulatory publishing software/tools.
- Ability to manage multiple concurrent projects with a strategic mindset.
- Comfortable working within SOP frameworks and contributing to process improvements.
- Experience supporting regulatory submissions and leading client engagements.
Regulatory Specialist employer: Albion Rye Associates
Contact Detail:
Albion Rye Associates Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Specialist
✨Tip Number 1
Familiarise yourself with the latest regulatory guidelines and marketing authorisation transfer (MAT) processes. This knowledge will not only help you in interviews but also demonstrate your commitment to staying updated in the field.
✨Tip Number 2
Network with professionals in the regulatory affairs sector, especially those who have experience in leading complex projects. Engaging with them can provide insights into the role and may even lead to referrals.
✨Tip Number 3
Prepare to discuss specific examples of your past experiences in managing regulatory projects and client engagements. Highlighting your leadership skills and ability to deliver high-quality outputs will set you apart.
✨Tip Number 4
Showcase your technical writing skills by being ready to discuss how you've prepared regulatory documents in the past. Being able to articulate your process and the impact of your work will impress potential employers.
We think you need these skills to ace Regulatory Specialist
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in regulatory affairs, particularly any leadership roles or projects you've managed. Use specific examples that demonstrate your expertise in the drug development lifecycle and regulatory strategies.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for regulatory affairs and your understanding of the role. Mention your experience with client engagement and project leadership, and explain how you can contribute to the company's success.
Highlight Technical Skills: In your application, emphasise your technical writing skills and familiarity with regulatory publishing software. Provide examples of high-quality documents you've prepared and any experience you have with SOP development.
Showcase Leadership Experience: If you have experience mentoring junior team members or leading complex projects, make sure to include this in your application. Highlight how your leadership has contributed to team success and project outcomes.
How to prepare for a job interview at Albion Rye Associates
✨Showcase Your Regulatory Expertise
Make sure to highlight your experience in regulatory affairs, especially your understanding of the drug development lifecycle and regional regulatory guidelines. Be prepared to discuss specific projects you've led and how you contributed to regulatory strategies.
✨Demonstrate Leadership Skills
As a Senior Regulatory Affairs Specialist, you'll need to lead complex projects. Share examples of how you've successfully managed teams or initiatives in the past, and be ready to explain your approach to mentoring junior team members.
✨Engage with Client-Centric Examples
Since client engagement is key, prepare to discuss how you've built and maintained strong relationships with clients. Think of instances where you provided proactive solutions or represented your team effectively in client meetings.
✨Prepare for Technical Discussions
Expect to delve into technical aspects during the interview. Brush up on your knowledge of regulatory documentation and be ready to discuss your experience with budget oversight and project management, ensuring you can articulate how you track activities and manage deviations.
